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Lifestyle Changes for Breast Cancer Risk Reduction

N/A
Recruiting
Led By Karen M Basen-Engquist
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to walk without an assistive device
No history of renal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights

Study Summary

This trial looks at how well a lifestyle intervention can reduce the risk of breast cancer in normal weight women by changing their body composition and decreasing inflammation.

Who is the study for?
This trial is for postmenopausal women who are of normal weight with a BMI between 18.5 and <25, have excess body fat, no history of invasive cancer except non-melanoma skin cancer, no major surgery within the last 3 months, can exercise safely, and work at MD Anderson Cancer Center but not directly under the study's principal investigator.Check my eligibility
What is being tested?
The trial tests if lifestyle changes like diet control and physical activities (resistance training and aerobic exercises) can reduce breast cancer risk by decreasing body fat and inflammation in normal-weight women with high breast cancer risk due to excess body fat.See study design
What are the potential side effects?
Since this intervention involves dietary changes and exercise programs rather than medication or medical procedures, side effects may include muscle soreness from exercise or discomfort from dietary adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own without needing help from devices.
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I have never had kidney disease.
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My BMI is between 18.5 and 25.
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I have never had cancer, except for non-melanoma skin cancer.
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My DXA scan shows I have a trunk fat mass of 9.4 kg or more.
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I am a postmenopausal woman.
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My BMI is between 18.5 and 25.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the exercise intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.
Evaluate the feasibility of a diet intervention to decrease body fat in postmenopausal women with normal BMI but high body. fat.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (lifestyle intervention)Experimental Treatment5 Interventions
Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
Group II: Group II (wait-list, lifestyle intervention)Active Control5 Interventions
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,284 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,792 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Foundation for Women's CancersUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project include participants who are above the age of 20?

"Prospective participants must be in between the ages of 50 and 69 to qualify for this medical study."

Answered by AI

What is the current participant enrollment level of this particular research?

"Affirmative. The clinical trial data hosted on clinicialtrials.gov reveals that the study is currently searching for 62 volunteers at one medical centre, beginning November 22nd 2021 and updated as of same date."

Answered by AI

What is the eligibility criteria for this research project?

"This trial is recruiting 62 postmenopausal women with breast cancer, aged between 50 and 69. Applicants must abide by the following requirements: Lack of menstruation for at least one year or bilateral oophorectomy, No prior renal disease, Capable to walk without aid, Not within 3 months of major surgery, Readily accessible internet access on a computer/mobile device and be employed at MD Anderson Cancer Center hospital, BMI >= 18.5 & < 25 kg/m^2 ,No negative responses in Physical Activity Readiness Questionnaire (otherwise have clearance from health care provider confirming fitness), No record of invasive cancers other"

Answered by AI

Has enrollment for this experiment opened up yet?

"According to clinicaltrials.gov, this research is actively recruiting participants with the trial first published on November 22nd 2021 and updated as recently as that same date."

Answered by AI
~18 spots leftby Apr 2025